A study to compare two drugs when added to levobupivacaine in lower limb surgeries

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/09/036808

Lead Sponsor: Rohilkhand medical college and hospital

Brief Summary: Spinal anaesthesia is popular and commonly used worldwide. It is economical and easy to administer and thus, commonly used technique for lower limb orthopaedicsurgeries. The advantages of a minimal drug costs, awake patient and rapid patient turnover has made this the method of choice for many surgical procedures.2 Post operative pain is common problem during lower limb orthopaedic surgeries under spinal anesthesia because spinal anesthesia using only local anesthetics is associated with relatively limited duration of action, and thus early analgesic intervention is needed in the postoperative period. So number of adjuvants, such as clonidine, fentanyl, dexmedetomidine and midazolam have been studied to prolong the spinal anesthesia effect.3

Dexmedetomidine and fentanyl are promising adjuncts to provide excellent and prolonged postoperative analgesia.5 Fentanyl is a potent synthetic opioid analgesic which is short-acting and highly lipophilic. It has been commonly used as an adjuvant to bupivacaine for postoperative analgesia.1Few studies have been done with fentanyl and dexmedetomidine as an adjuvant to levobupivacaine in obstetric patients. We have not come across any study on use of fentanyl and dexmedetomidine in lower doses as an adjuvant to levobupivacaine.

Hence, in this study we propose to compare a combination of isobaric levobupivacaine with fentanyl versus dexmedetomidine in low dose for the characteristics of spinal blockade with respect to onset, duration and hemodynamic parameters and side effect.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

ASA I or II Age between 19 to 65 years Either sex Patient posted for elective lower limb surgery.

Exclusion Criteria

Patient refusal for procedure Patientâ€™s contraindications to spinal anaesthesia (eg: deranged coagulation profile ) Obesity (BMI>30kg/m2) Any neuropathies Patients receiving Opioids for chronic analgesic therapy Allergy or intolerance to local anaesthetics Patients on beta-blocker or known dysrhythmia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset and duration of motor and sensory blockade	On Day 1

Secondary Outcome Measures

Name	Time	Method
Haemodynamic changes , post - op shivering and emesis	On Day 1

Trial Locations

Locations (1): Rohilkhand medical college and hospital
🇮🇳
Bareilly, UTTAR PRADESH, India
Rohilkhand medical college and hospital
🇮🇳Bareilly, UTTAR PRADESH, India
Dr Gulwatan Singh Kang
Principal investigator
7986561752
gulwatansingh@gmail.com